A variety of therapeutic regimens have been used for treating acute exposure to lipophilic toxins, and these primarily employ systemic support in combination with measures to reduce absorption and improve elimination, such as emetics and enemas. None of these are entirely satisfactory for treating an acute poisoning, and by their nature all of them are unsuitable for detoxification following chronic exposure.
White mineral oils or "paraffin oils" are polycyclic high-boiling petroleum fractions that have been decolorized by activated diatomaceous clay or crude aluminum oxide. C. R. Noller, Chemistry of Organic Compounds, 2nd. Ed. (1957). p. 82. Mineral oil is a well-known laxative and has been suggested for use as a kind of "intestinal solvent" to dissolve lipophilic toxins and cause their removal in bodily wastes. S. Moeschlin, Klinik and Therapie der Vergiftungen, 4th Ed. (1964); Richter, E., Chemosphere 6(6):357-369 (1977). However, mineral oil is partially absorbed by the body and undesirably deposits in the liver and other tissues. E. Fingl, "Laxatives and Cathartics" in The Pharmacological Basis of Therapeutics, 5th Ed., (1975), L. S. Goodman and A. Gilman, eds., p. 978. See also Becker, G. L., Am. J. Dig. Dis. 1952, 19:355-348. The polyesters herein, in contrast with mineral oil, are not absorbed and/or deposited in the liver during usage in a treatment/prevention regimen. Coh, W. J., et al., N. Eng. J. Med. 298(5):243-248 (1978) discloses the use of cholestryamine, an ion-exchange resin, to treat the toxic effects of Kepone.
Treatment of endogenous disease states, such as hypercholesterolemia, with the polyesters employed in the present invention is known to the art. Relevant patents include: U.S. Pat. No. 3,600,186 issued Aug. 17, 1971 to Mattson, et al., which discloses and claims a low calorie, fat-containing food composition where from about 10% to about 100% of the total fat consists of polyol fatty cid polyesters.
U.S. Pat. No. 3,954,976 issued May 4, 1976 to Mattson, et al., encompasses polyol fatty acid polyesters in 0.1-5 gram unit doses as pharmaceutical compositions for inhibiting the absorption of cholesterol.
U.S. Pat. No. 3,963,699 issued June 15, 1976 to Rizzi, et al., relates to a solvent-free esterification process for preparing the polyol fatty acid polyesters. A sugar, a fatty acid C.sub.1 -C.sub.2 alkyl ester, an alkali metal fatty acid soap and a base catalyst (alkali metal alloys, alkali metal hydrides, alkali metal alkoxides) are heated to form a homogeneous melt; excess fatty acid alkyl ester is added to form the polyol fatty acid polyester, which is then separated from the mixture. The process allows drug-quality polyol fatty acid polyesters to be manufactured without a solvent-removal step.
U.S. Pat. No. 4,005,195 issued Jan. 25, 1977 to Jandacek describes anti-anal leakage (AAL) agents used in combination with the liquid polyol fatty acid polyesters. The disclosure relates to: (1) compositions of matter comprising polyol fatty acid polyesters+anti-anal leakage compounds; (2) low calorie foods with polyol fatty acid polyesters+AAL compounds; (3) polyol fatty acid polyesters+AAL in unit dose form (0.1-5 grams) as pharmaceuticals; and (4) methods for treating hypercholesterolemia by inhibiting absorption of cholesterol without anal leakage by administering compositions per (1).
U.S. Pat. No. 4,005,196 issued Jan. 25, 1977 to Jandacek, et al., encompasses compositions comprising fat-soluble vitamins in combination with polyol fatty acid polyesters and anti-anal leakage agents.
U.S. Pat. No. 4,034,083 issued July 5, 1977 to Mattson, discloses polyol fatty acid polyesters+fat-soluble vitamins.
The disclosures of the foregoing patents are incorporated herein by reference.